An observational study in Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma and Advanced Pancreatic Adenocarcinoma, sponsored by Kaiser Permanente. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Kaiser Permanente · Observational
The UNCOVER study is a longitudinal observational cohort focused on patients at high risk for cancer cachexia. At Kaiser Permanente Northern California, up to 800 individuals with advanced or unresectable non-small cell lung cancer, pancreatic adenocarcinoma, or colorectal cancer will be enrolled, as these malignancies carry a substantial risk of cancer cachexia, which is characterized by progressive loss of weight, muscle, and adipose tissue, accompanied by functional decline and reduced quality of life. Data collected includes demographic, physiologic, and clinical data, including tumor characteristics and biomarkers of inflammation, hormonal and metabolic status, body composition, physical function, and patient reported outcomes. Investigators will identify patient phenotypes (i.e., subgroups) that may reflect distinct biological or clinical pathways underlying cancer cachexia. By characterizing heterogeneity in cancer cachexia, this study aims to inform the development of improved diagnostic criteria and more targeted therapeutic strategies, ultimately enhancing clinical trial design and supportive care for patients with advanced colorectal, lung, or pancreatic cancer.
PRIMARY OBJECTIVES:
I. To identify multiple distinct diagnostic phenotypes within the syndrome of cancer cachexia as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for cancer cachexia.
II. To determine the association of each cancer cachexia phenotype with overall survival.
SECONDARY OBJECTIVES:
I. To determine the association of each cancer cachexia phenotype with functional decline and treatment intolerance.
II. To inform clinical practice guidelines for prompt recognition of patients likely to progress to refractory cachexia, identify early predictors apparent at clinical presentation of each cancer cachexia phenotype defined in the primary objective.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 800 is above the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients undergoing treatment for non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, or colorectal cancer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Note: Patients do not need to have cachexia to be eligible
Note: Patients who received systemic anti-cancer therapy previously as part of or neoadjuvant therapy and have since recurred are still eligible if such treatment was longer than 6 months prior to enrollment.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients complete surveys, undergo physical function tests, undergo collection of blood and archived tumor samples, and wear an actigraph over 24 hours for a week to record daily sleep and exercise activity at baseline and 3-month follow-up. A sub-sample of patients provide stool samples. Additionally, patients undergo standard of care CT or PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.
Procedure: Biospecimen Collection · Procedure: Computed Tomography · Other: Electronic health record review · Other: Medical Device Usage and Evaluation · Other: Physical functions assessments · Procedure: Positron Emission Tomography (PET) · Other: Survey Administration
Undergo collection of blood and archived tumor samples. A sub-sample undergo collection of stool samples.
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo CT or PET/CT scan
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Electronic Health Record Review
Wear actigraph
Undergo physical function assessments including 30-second bicep curl, timed up and go (TUG), and 30-second sit to stand
Also known as: Physical Fitness Testing, Physical Function Testing
Undergo PET/CT scan
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Complete surveys
Multiple distinct diagnostic cancer cachexia phenotypes
Phenotypes will be based on patient-reported symptoms, physical activity and function assessments, biomarkers, and body composition measured longitudinally using latent class analysis and other clustering methods.
Time frame: Baseline through study completion, assessed up to 1 year follow up
Overall survival: time to death
Time to death will be assessed as the interval between phenotype ascertainment and death from any cause. Participants without a recorded death event will be censored at the end of available follow-up (e.g., end of health plan membership or the study observation period).
Time frame: Baseline to death (the event) or the last contact (censored), assessed up to 1 year follow up
Functional decline
Associations between each cancer cachexia phenotype and functional decline is a secondary outcome. Functional status will be measured at baseline and study completion by physical function assessments and patient-reported questionnaires.
Time frame: Baseline through study completion, assessed up to 1 year follow up
Treatment intolerance
Treatment intolerance will be modeled as time to event outcomes. Treatment data including chemotherapy, targeted therapy, and immunotherapy will be obtained from the electronic medical record.
Time frame: Baseline through study completion, assessed up to 1 year follow up
Early predictors of decline
Logistic regression will be used to identify patient characteristics apparent at clinical presentation that are early predictors of each cancer cachexia phenotype, focusing on the high-risk phenotypes that are associated with poor outcomes.
Time frame: Baseline through study completion, assessed up to 1 year follow up
Started Apr 2023 (actual). Primary completion is estimated for May 2027, 49 months after the start.
Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 49 months is below that.
Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
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